Class II
Terminated
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
- Recall Initiated
- June 26, 2014
- Posted
- August 13, 2014
- Recall Number
- D-1510-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 70,152 bottles; b) 43,525 bottles
- Firm Location
- Detroit, MI, United States
Reason for Recall
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15
More recalls by Caraco Pharmaceutical Laboratories, Ltd.
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Cou...
Jul 9, 2014 · Class II
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial...
Jul 2, 2014 · Class II
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 416...
May 7, 2014 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026