Ranbaxy Recalls Absorica LD Isotretinoin Capsules Due to Undeclared Dye
Ranbaxy Inc. is recalling 9,229 boxes of Absorica LD (isotretinoin) capsules because the capsule shells contain undeclared FD&C Yellow No. 5.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves an undeclared excipient (dye) without reported illnesses or injuries, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Ranbaxy Inc. is recalling 9,229 boxes of Absorica LD (isotretinoin) capsules, 25 mg, packaged in 3 x 10 count blister cards. The affected product is Lot #14H04AA with an expiration date of 02/28/2017. The recall is due to the presence of undeclared FD&C Yellow No. 5 in the capsule shell.
The product was distributed nationwide. Absorica LD is a prescription-only medication manufactured for Ranbaxy Laboratories, Inc. The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- ABSORICA LD (ISOTRETINOIN)
- Brand
- ABSORICA LD
- Manufacturer
- Ranbaxy Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 9,229
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #:14H04AA
- Expiry: 02/28/2017.
Distribution
Distributed nationwide across the United States.
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